FDA 510(k)

LED light therapy mask (FM-01, FM-02, FM-03)

Número K: K223544 · 2023-02-23

RequerenteGuangdong Newdermo Biotech Co., Ltd.

Data da decisão2023-02-23

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED light therapy mask (FM-01, FM-02, FM-03) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223544. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LED light therapy mask (FM-01, FM-02, FM-03)?

LED light therapy mask (FM-01, FM-02, FM-03) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K223544.

When did LED light therapy mask (FM-01, FM-02, FM-03) receive FDA 510(k) clearance?

LED light therapy mask (FM-01, FM-02, FM-03) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223544.

Who is the listed applicant for LED light therapy mask (FM-01, FM-02, FM-03)?

The FDA 510(k) record lists Guangdong Newdermo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED light therapy mask (FM-01, FM-02, FM-03)?

The FDA product code for LED light therapy mask (FM-01, FM-02, FM-03) is OHS.

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Outros registros que listam Guangdong Newdermo Biotech Co., Ltd. como candidato(a)

K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)K260946Máscara de Terapia de Luz LED (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K260202LED Light Therapy Masks (LumiLips FAC07NA)

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